Identity
- Trade Name
- Faxitron Core FDA UDI
- Generic Name
- Stationary specimen x-ray system, digital FDA UDI
- Model / Reference
- CoreVision 5x10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857069006272 FDA UDI
- 510(k) Number
- K082432 FDA UDI
- FDA Product Code
- MWP FDA UDI
- GMDN Term
- Stationary specimen x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary specimen x-ray system, digital
Faxitron Core by Faxitron Bioptics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Stationary specimen x-ray system, digital.
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- Faxitron — Faxitron Bioptics, LLC · Class II
- Faxitron — Faxitron Bioptics, LLC · Class II
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Cleared under the same submission
K082432 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Faxitron Bioptics, LLC
Sources (1)
- FDA UDI 1162bd24-fa8b-4b10-8036-29908e8c6af3 33 fields · synced Jun 8, 2026